Head of IT Compliance and Service Excellence

PolyPeptide / Full-time

PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting customers mainly within pharma and biotech, PolyPeptide contributes to the health of millions of patients across the world.

PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. Dating back to 1952, PolyPeptide today operates a global network across Europe, the U.S. and India and employs more than 1,200 people globally.

PolyPeptide’s Values

Trust: PolyPeptide builds and maintains trust in all relationships, both internally and with customers. Collaboration and supporting each other are central to how the organization works.

Innovation: PolyPeptide values curiosity and the drive to find smart solutions to the challenges the organization faces.

Excellence: PolyPeptide strives to deliver high quality and continuously adapt to meet the needs of its customers.

About the Role

As Head of IT Compliance and Service Excellence at PolyPeptide, you will lead and further develop the global IT Compliance and Service Excellence function within Global IS/IT.

You will lead a team of seven experienced specialists based in Sweden and India and become part of the Global IS/IT management team. This is first and foremost a people leadership role, where you will set direction, create clarity, develop capabilities and enable the team to perform at its best.

PolyPeptide already has a mature IT compliance setup. Going forward, an important part of the role will be to continue modernizing the approach to compliance and validation as the technology landscape increasingly moves towards cloud-based services and continuous updates, while maintaining the high standards required in a GxP-regulated environment.

You will work closely with Global Quality Assurance, validation functions, Information and Cybersecurity, site IT and business stakeholders and represent the function in management forums, audits and inspections.

Key Responsibilities

• Lead, develop and coach the global IT Compliance and Service Excellence team
• Set direction and priorities and translate Global IS/IT objectives into actionable plans
• Develop and continuously improve PolyPeptide’s global IT compliance and quality framework
• Provide management oversight of GxP compliance and computerized system validation
• Promote pragmatic and risk-based approaches to compliance and validation
• Support audits, inspections, customer reviews and certification activities
• Drive ITIL-based service excellence, standardization and continuous improvement
• Build strong collaboration across Global IS/IT, Quality, validation, site functions and business stakeholders
• Represent the function in relevant management forums, audits and inspections

Important Stakeholders

• Global Quality Assurance
• Global IS/IT management
• Validation functions
• Information and Cybersecurity
• Site IT and business stakeholders
• External auditors, customers and suppliers

Your Profile

To succeed in this role, you are an experienced people leader with a solid background in IT compliance and regulated environments. You do not need to be the deepest specialist within every area, but you have the professional understanding required to lead experienced specialists, challenge constructively and represent the function credibly across the organization.

PolyPeptide is looking for a candidate with:

• Documented people management experience, preferably leading experienced specialists
• Several years of experience within IT compliance, GxP, computerized system validation, IT governance or related areas
• Strong knowledge of GAMP 5, computerized system validation and inspection readiness
• Experience from pharma, biotech or another regulated industry
• Understanding of ITIL principles, service management and continuous improvement
• Knowledge of ISO/IEC 27001 and risk-based ways of working
• Experience supporting or leading audits and compliance activities
• Strong stakeholder management and communication skills
• Fluent verbal and written English

Certifications within ITIL, CISA, ISO 27001 or GAMP/CSV are considered an advantage.

Personal Characteristics

You are a confident and engaging leader who creates clarity, builds trust and enables experienced specialists to succeed.

You are comfortable navigating a highly regulated environment while challenging established ways of working when there is an opportunity to simplify or modernize. You balance compliance with progress and communicate effectively across technical, quality and management functions.

As a leader, you adapt your approach to different individuals and cultures and are motivated by developing both people and the function around you.

Find this interesting? Apply now

Are you ready to take the next step in your career? Applications are reviewed on an ongoing basis, so do not hesitate to submit your CV.

This recruitment is assisted by Capax Recruitment. For more information, please contact Rikke Hummelmose at rmi@capaxrecruitment.com.

Please note: PolyPeptide only accepts applications submitted via the specified application link. Applications sent by email or other means will not be considered and will be deleted without review.